Medication Overuse Headache
Conditions
Brief summary
Efficacy and Safety Pilot Study of DFN-11 Injection in Medication Overuse Headache
Interventions
DRUGDFN-11 Injection
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of medication overuse headache within the past year in the following categories 2. Diagnosis of migraine, with or without aura for at least 12 months 3. Experience an average of \> 10 headache days per month for the past 12 months 4. Females must: i. be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method \[e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel\], or male partner sterilization) before entry and willing to continue throughout the study, or ii. be surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or iii. be postmenopausal (spontaneous amenorrhea for at least 1 year) 5. Females of child-bearing potential must have a negative urine pregnancy test at all visits. 6. Able and willing to read and comprehend written instructions and complete the electronic diary. 7. Must have internet access to complete daily headache diary.
Exclusion criteria
1. Current use of medication for headache/migraine prophylaxis that has not been stable for 30 days prior to screening. Stable is defined as no recent dosing change within 30 days of screening. 2. Hemiplegic or basilar migraine 3. History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes 4. Uncontrolled hypertension (screening systolic/diastolic blood pressure \> 140/90 mmHg in 2 out of 3 readings) 5. Clinically significant hepatic impairment 6. History of epilepsy or conditions associated, which in the opinion of the Investigator, increase the likelihood of present day seizure 7. History (within 2 years) of drug or alcohol abuse as defined by DSM-IV-TR criteria 8. Systemic disease, which in the opinion of the Investigator, would contraindicate participation 9. History of a neurological or psychiatric condition, which in the opinion of the Investigator would contraindicate participation 10. Pregnant or lactating women 11. Have taken any investigational medication within 30 days before screening, or are scheduled to receive an investigational drug 12. Subjects with a positive urine drug screen for recreational drugs or marijuana (whether legal or not) or for prescription drugs not explained by stated concomitant medications 13. Clinical laboratory or electrocardiogram (ECG) abnormality that in the opinion of the Investigator would endanger the subject or interfere with the study conduct. If the results of the clinical laboratory or ECG are outside of normal reference range the subject may still be enrolled but only if these findings are determined to be not clinically significant by the Investigator. This determination must be recorded in the subject's source document prior to enrolment. 14. Fridericia's corrected QT (QTcF) interval greater than 450 msec 15. Severe renal impairment (creatinine \> 2 mg/dl) 16. Serum total bilirubin \> 2.0 mg/dL 17. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase \> 2.5 times the upper limit of normal 18. Subjects with uncontrolled diabetes mellitus, or a glycosylated hemoglobin (HbA1c) \> 7.0%, or with diabetes mellitus requiring insulin 19. Subjects who in the opinion of the investigator experience rebound headache from caffeine usage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) | 28 days Baseline period and 28 days of Treatment period (Total 56 days) |
Secondary
| Measure | Time frame |
|---|---|
| The Number of Acute Headache Medication Doses in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) | 28 days Baseline period and 28 days of Treatment period (Total 56 days) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DFN-11 DFN-11 Injection upon occurrence of migraine | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Baseline | Did not meet continued criteria | 5 |
| Screening | Did not meet entry criteria | 12 |
| Treatment Period | Adverse Event | 1 |
Baseline characteristics
| Characteristic | DFN-11 |
|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 11.94 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 5 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
The Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches)
Time frame: 28 days Baseline period and 28 days of Treatment period (Total 56 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DFN-11 | The Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) | Baseline period | 202.82 Hours | Standard Deviation 152.58 |
| DFN-11 | The Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) | Treatment period | 138.71 Hours | Standard Deviation 113.6 |
Secondary
The Number of Acute Headache Medication Doses in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches)
Time frame: 28 days Baseline period and 28 days of Treatment period (Total 56 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DFN-11 | The Number of Acute Headache Medication Doses in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) | Baseline period | 16.56 Number of doses of acute medication used | Standard Deviation 3.43 |
| DFN-11 | The Number of Acute Headache Medication Doses in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) | Treatment period | 19.78 Number of doses of acute medication used | Standard Deviation 10.13 |